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Economic evaluation of treatment modalities for position dependent obstructive sleep apnea patients

Economic evaluation of treatment modalities for position dependent obstructive sleep apnea patients - Economic evaluation of treatment modalities for POSA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44815
Enrollment
130
Registered
2018-01-12
Start date
2015-09-18
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea sydrome (OSAS) sleep-disordered breathing (SDB)

Interventions

The SPT trains POSA patients to sleep in non-supine positions, CPAP uses positive airway pressure to open the airway
MRA is an intra-oral prosthesis, which holds the mandible in a protrusive position, all to prevent effectively apneic events.
Continuous positive airway pressure
Cost-effectiveness
Mandibular advancement device

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Diagnosis with symptomatic mild or moderate OSA (15 as high as AHI non-supine.

Exclusion criteria

Exclusion criteria: - Many dental problems; insufficient teeth for wearing MRA - Medication used/ related to sleeping disorders - Central Sleep Apnea Syndrome. - Night or shifting work. - Severe chronic heart failure, - Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy). - Seizure disorder. - Known medical history of mental retardation, memory disorders or psychiatric disorders. - Shoulder, neck and back complaints. - Reversible morphological upper airway abnormalities (e.g. enlarged tonsils), - Inability to provide informed consent. - Simultaneous use of other treatment modalities to treat OSA. - Previous treatment for OSA with MRA, CPAP or SPT - Pregnancy

Design outcomes

Primary

MeasureTime frame
primary ouctome: AHI

Secondary

MeasureTime frame
1) Outcome of Quality of Life questionnaires; EQ-5D, ESS and FOSQ. 2) (Societal) costs of treatment; Healthcare Consumption, Illness and Work (HCIW) questionnaire (PCQ/MCQ, successors of TiC-P and PRODISQ). 3) Compliance, i.e. more than 4 hours of usage per night. 4) Cardiovascular parameters: blood pressure, pulse rate, BMI and neck circumference

Countries

Belgium, Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)